Reported Feb 19, 2020 · Terminated
ROSA Brain 3.0 Application-Brain
Medtech Sas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDTECH SAS · 900 Rue Du Mas De Verchant · Montpellier · N/A
Is this the product you have?
- ROSA Brain 3.0 Application-Brain
- Lot codes and dates
70 of 70 products
Products covered by this recall # Barcodes Product as published 1 03760244031754BR17030 / UDI - (01)03760244031754(11)180309(21)BR17030 2 03760244031754BR17034, BS17934 / UDI - (01)03760244031754(11)180315(21)BR17034 3 03760244031754BR17035, BS17935 / UDI - (01)03760244031754(11)180315(21)BR17035 4 03760244031754BR17036 / UDI - (01)03760244031754(11)180417(21)BR17036 5 03760244031754BR17037, BS17937 / UDI - (01)03760244031754(11)180313(21)BR17037 6 03760244031754BR18024 / UDI - (01)03760244031754(11)180321(21)BR18024 7 03760244031754BR18031 / UDI - (01)03760244031754(11)180309(21)BR18031 8 03760244031754BR18038 / UDI - BS18938 "(01)03760244031754(11)180430(21)BR18038 9 03760244031754BR18039 / UDI - (01)03760244031754(11)180416(21)BR18039 10 03760244031754BR18040, BS18940 / UDI - (01)03760244031754(11)180427(21)BR18040 11 03760244031754BR18041, BS18941 / UDI - (01)03760244031754(11)180329(21)BR18041 12 03760244031754BR18042 / UDI - (01)03760244031754(11)180420(21)BR18042 13 03760244031754BR18043, BS18943 / UDI - (01)03760244031754(11)180503(21)BR18043 14 03760244031754BR18045, BS18945 / UDI - (01)03760244031754(11)180504(21)BR18045 15 03760244031754BR18046, BS18946 / UDI - (01)03760244031754(11)180515(21)BR18046 16 03760244031754BR18047 / UDI - (01)03760244031754(11)180413(21)BR18047 17 03760244031754BR18048, BS18948 / UDI - (01)03760244031754(11)180608(21)BR18048 18 03760244031754BR18049, BS18949 / UDI - (01)03760244031754(11)180625(21)BR18049 19 03760244031754BR18050 / UDI - (01)03760244031754(11)180531(21)BR18050 20 03760244031754BR18051, BS18951 / UDI - (01)03760244031754(11)180605(21)BR18051 - Amount recalled
- 47 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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